Effect of reduced dose schedules and intramuscular injection of anthrax vaccine adsorbed on immunological response and safety profile: A randomized trial

Vaccine

Volumn 32, Issue 8, 2014, Pages 1019-1028

  Wright, Jennifer G ^a   Plikaytis, Brian D ^a   Rose, Charles E ^a   Parker, Scott D ^b,g   Babcock, Janiine ^c,h   Keitel, Wendy ^d   El Sahly, Hana ^d   Poland, Gregory A ^e   Jacobson, Robert M ^e   Keyserling, Harry L ^f   Semenova, Vera A ^a   Li, Han ^a   Schiffer, Jarad ^a   Dababneh, Hanan ^a   Martin, Sandra K ^a   Martin, Stacey W ^a   Marano, Nina ^a   Messonnier, Nancy E ^a   Quinn, Conrad P ^a  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c Walter Reed Army Institute for Research   (United States)

^d BAYLOR COLLEGE OF MEDICINE   (United States)

^e MAYO CLINIC   (United States)

^f EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g Infectious Disease Consultants   (United States)

^h SEATTLE CHILDREN S HOSPITAL   (United States)

Author keywords

Adverse events; Anthrax vaccines; Bacillus anthracis; Bacterial vaccines; Vaccination

Indexed keywords

ANTHRAX VACCINE; PLACEBO; SODIUM CHLORIDE;

ADULT; AGED; ANTHRAX; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG SAFETY; FATIGUE; FEMALE; FEVER; FOOD AND DRUG ADMINISTRATION; HEADACHE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IMMUNOLOGICAL MEMORY; INJECTION SITE CONTUSION; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE NODULE; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INJECTION SITE WARMTH; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MYALGIA; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; VACCINATION;

ADVERSE EVENT; ADVERSE EVENTS; AE; ANTHRAX VACCINE ADSORBED; ANTHRAX VACCINE RESEARCH PROGRAM; ANTHRAX VACCINES; AVA; AVRP; BACILLUS ANTHRACIS; BACTERIAL VACCINES; CDC; CENTERS FOR DISEASE CONTROL AND PREVENTION; DEPARTMENT OF DEFENSE; DOD; FDA; FOOD AND DRUG ADMINISTRATION; GCP; GOOD CLINICAL PRACTICES; IM; IND; INTRAMUSCULARLY; INVESTIGATIONAL NEW DRUG; LETHAL TOXIN; LTX; PA; PROTECTIVE ANTIGEN; SQ; SUBCUTANEOUS; UNITED STATES ARMY MEDICAL MATERIEL AGENCY; USAMMA; VACCINATION;

ADULT; ANTHRAX; ANTHRAX VACCINES; ANTIBODIES, BACTERIAL; ANTIBODY FORMATION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNIZATION, SECONDARY; IMMUNOGLOBULIN G; INJECTIONS, INTRAMUSCULAR; MALE; MIDDLE AGED;

EID: 84892998422     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.10.039     Document Type: Article

References (46)

1. Anthrax Vaccine Adsorbed. United States patent US 3208909; September 28, 1965.
2. BioThrax (anthrax vaccine adsorbed) [Vaccine package insert] 2008, Emergent BioSolutions, Rockville, MD.
3. Brachman P.S., Gold H., Plotkin S.A., Fekety F.R., Werrin M., Ingraham N.R. Field evaluation of a human anthrax vaccine. Am J Public Health Nations Health 1962, 52(4):632-645.
4. Wright G.G., Green T.W., Kanode R.G. Studies on immunity in anthrax. V. Immunizing activity of alum-precipitated protective antigen. J Immunol 1954, 73:387-391.
5. Tresselt H.B., Boor A.K. An antigen prepared in vitro effective for immunization against anthrax. III. Immunization of monkeys against anthrax. J Infect Dis 1955, 97:207-210.
6. Turnbull P.C., Broster M.G., Carman J.A., Manchee R.J., Melling J. Development of antibodies to protective antigen and lethal factor components of anthrax toxin in humans and guinea pigs and their relevance to protective immunity. Infect Immun 1986, 52:356-363.
7. Little S.F., Knudson G.B. Comparative efficacy of Bacillus anthracis live spore vaccine and protective antigen vaccine against anthrax in the guinea pig. Infect Immun 1986, 52:509-512.
8. Ivins B.E., Ezzell J.W., Jemski J., Hedlund K.W., Ristroph J.D., Leppla S.H. Immunization studies with attenuated strains of Bacillus anthracis. Infect Immun 1986, 52:454-458.
9. Darlow H., Belton F., Henderson D. The use of anthrax antigen to immunise man and monkey. Lancet 1956, 271:476-479.
10. Auerbach S., Wright G.G. Studies on immunity in anthrax. VI. Immunizing activity of protective antigen against various strains of Bacillus anthracis. J Immunol 1955, 75:129-133.
11. Ward M.K., McGann V.G., Hogge A.L., Huff M.L., Kanode R.G., Roberts E.O. Studies on anthrax infections in immunized guinea pigs. J Infect Dis 1965, 115:59-67.
12. Ivins B., Fellows P., Pitt M. Efficacy of a standard human anthrax vaccine against Bacillus anthracis aerosol spore challenge in rhesus monkeys. Salisbury Med Bull 1995, 87(Suppl. 125-126).
13. Pitt M., Ivins B.E., Estep J.E., Farchaus J., Friedlander A.M. Comparison of the efficacy of purified protective antigen and MDPH to protect non-human primates from inhalation anthrax. Salisbury Med Bull 1996, 87:130.
14. Ivins B.E., Pitt M.L., Fellows P.F., Farchaus J.W., Benner G.E., Waag D.M., et al. Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in Rhesus macaques. Vaccine 1998, 16:1141-1148.
15. Cohen WA, The Secretary of Defense. Implementation of the Anthrax Vaccination Program for the Total Force. May 18, 1998. [accessed 13.06.11]. http://www.vaccines.mil/documents/902implementationpolicy.pdf.
16. Pittman P.R., Kim-Ahn G., Pifat D.Y., Coonan K., Gibbs P., Little S., et al. Anthrax vaccine: immunogenicity and safety of a dose-reduction, route-change comparison study in humans. Vaccine 2002, 20(9-10):1412-1420.
17. Pittman P.R., Mangiafico J.A., Rossi C.A., Cannon T.L., Gibbs P.H., Parker G.W., et al. Anthrax vaccine: increasing intervals between the first two doses enhances antibody response in humans. Vaccine 2000, 19(2-3):213-216.
18. Joellenbeck L., Zwanziger L.L., Durch J.S., Strom B.L. The anthrax vaccine: is it safeα Does it workα 2002, National Academy Press, Washington, DC.
19. Marano N., Plikaytis B.D., Martin S.W., Rose C., Semenova V.A., Martin S.K., et al. Effects of a reduced dose schedule and intramuscular administration of anthrax vaccine adsorbed on immunogenicity and safety at 7 months: a randomized trial. JAMA 2008, 300:1532-1543.
20. Sun W, Food and Drug Administration. Biologics license application supplement approval letter. December 11, 2008. Available at [accessed 13.06.11]. http://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm124462.htm.
21. Quinn C.P., Semenova V.A., Elie C.M., Romero-Steiner S., Greene C., Li H., et al. Specific, sensitive, and quantitative enzyme-linked immunosorbent assay for human immunoglobulin G antibodies to anthrax toxin protective antigen. Emerg Inf Dis 2002, 8(10):1103-1110.
22. Semenova V.A., Steward-Clark E., Stamey K.L., Taylor T.H., Schmidt D.S., Martin S.K., et al. Mass value assignment of total and subclass immunoglobulin G in a human standard reference serum. Clin Diagn Lab Immunol 2004, 11(5):919-923.
23. Plikaytis BD, Holder PF, Carlone GM. ELISA for Windows user's manual, version 2.00. [accessed 14.09.11]. http://www.cdc.gov/ncidod/dbmd/bimb/ELISA.htm.
24. Soroka S.D., Schiffer J.M., Semenova V.A., Li H., Foster L., Quinn C.P. A two stage multilevel quality control system for serological assays in anthrax vaccine clinical trials. Biologicals 2010, 38(6):675-683.
25. Soroka S.D., Taylor T.H., Freeman A.E., Semenova V.A., Plikaytis B.D., Quinn C.P. A new mathematical approach to calculating dilutional titer endpoints (abstract No. P34). Bacillus ACT05 international conference on Bacillus anthracis, B. thuringiensis and B. cereus 2005.
26. Hornung R.W., Reed L.D. Estimation of average concentration in the presence of nondetectable values. Appl Occup Environ Hyg 1990, 5:46-51.
27. Li H., Soroka S.D., Taylor T.H., Stamey K.L., Stinson K.W., Freeman A.E., et al. Standardized, mathematical model-bases and validated in vitro analysis of anthrax lethal toxin neutralization. J Immunol Methods 2008, 33:89-106.
28. Hering D., Thompson W., Hewetson J., Little S., Norris S., Pace-Templeton J. Validation of the anthrax lethal toxin neutralization assay. Biologicals 2004, 32:17.
29. Lu H., Catania J., Baranji K., Feng J., Gu M., Lathey J., et al. Characterization of the native form of anthrax lethal factor for use in the toxin neutralization assay. Clin Vaccine Immunol 2013, 20(July (7)):986-997.
30. Castelán-Vega J., Corvette L., Sirota L., Arciniega J. Reduction of immunogenicity of anthrax vaccines subjected to thermal stress, as measured by a toxin neutralization assay. Clin Vaccine Immunol 2011, 18(February (2)):349-351.
31. Omland K.S., Brys A., Lansky D., Clement K., Lynn F. Participating laboratories. Interlaboratory comparison of results of an anthrax lethal toxin neutralization assay for assessment of functional antibodies in multiple species. Clin Vaccine Immunol 2008, 15(June (6)):946-953.
32. "What is a Serious Adverse Eventα". US Food and Drug Administration, page last updated 23.06.11. [accessed 02.09.11]. http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm.
33. Causality assessment of adverse events following immunization. Wkly Epidemiol Record 23 March 2011, 12(76):85-92. [accessed 30.01.12]. http://www.who.int/vaccine_safety/causality/en/.
34. Schuirmann D.J. A comparison of the two onesided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987, 15(6):657-680.
35. Phillips K.F. Power of the two one-sided tests procedure in bioequivalence. J Pharmacokinet Biopharm 1990, 18(2):137-144.
36. Farrington C.P., Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or nonunity relative risk. Stat Med 1990, 9(12):1447-1450.
37. Ionin B., Hopkins R.J., Pleune B., Sivko G.S., Reid F.M., Clement K.H., et al. Evaluation of immunogenicity and efficacy of anthrax vaccine adsorbed for postexposure prophylaxis. Clin Vaccine Immunol 2013, 20(July (7)):1016-1020.
38. Livingston B.D., Little S.F., Luxembourg A., Ellefsen B., Hannaman D. Comparative performance of a licensed anthrax vaccine versus electroporation based delivery of a PA encoding DNA vaccine in Rhesus macaques. Vaccine 2010, 28(January (4)):1056-1061.
39. Marcus H., Danieli R., Epstein E., Velan B., Shafferman A., Reuveny S. Contribution of immunological memory to protective immunity conferred by a Bacillus anthracis protective antigen-based vaccine. Infect Immun 2004, 72(June (6)):3471-3477.
40. CDC Use of anthrax vaccine in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb Mort Wkly Rep 2009, 59(RR-6). July 23, 2010.
41. Quinn C.P., Sabourin C.L., Niemuth N.A., Li H., Semenova V.A., Rudge T.L., et al. A three dose intramuscular schedule of anthrax vaccine adsorbed generates sustained humoral and cellular immune responses to protective antigen and provides long term protection against inhalation anthrax in Rhesus macaques. Clin Vaccine Immunol 2012, 19(11):1730-1745.
42. Madigan D. 8 November 2007. Anthrax vaccines: bridging correlates of protection in animals to immunogenicity in humans. Washington, DC: Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services. [accessed 06.07.12]. http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/UCM054424.pdf.
43. Eickhoff T.C., Myers M. Workshop summary. Aluminum in vaccines. Vaccine 2002, 20(May (Suppl. 3)):S1-S4.
44. Campbell J.D., Clement K.H., Wasserman S.S., Donegan S., Chrisley L., Kotloff K.L. Safety, reactogenicity and immunogenicity of a recombinant protective antigen anthrax vaccine given to healthy adults. Hum Vaccine 2007, 3:205-211.
45. Gorse G.J., Keitel W., Keyserling H., Taylor D.N., Lock M., Alves K., et al. Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA102) anthrax vaccine: a randomized, double-blinded, controlled, multicenter trial. Vaccine 2006, 24:5950-5959.
46. Brown B.K., Cox J., Gillis A., VanCott T.C., Marovich M., Milazzo M., et al. Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults. PLoS One 2010, 5(November (11)):e1384P.